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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K923911
Device Name INTRINSIC STEM
Applicant
Turnkey Intergration USA, Inc.
8021 Knue Rd., Suite 121
Indianapolis,  IN  46250
Applicant Contact JERRY KEYES
Correspondent
Turnkey Intergration USA, Inc.
8021 Knue Rd., Suite 121
Indianapolis,  IN  46250
Correspondent Contact JERRY KEYES
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received08/04/1992
Decision Date 04/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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